The Metabolic and Circadian Effects of Shift Work - An Observational Study

Tinh-Hai Collet, MD1 site in 1 country72 target enrollmentFebruary 1, 2022

ConditionsShift Work Schedule

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Shift Work Schedule
Sponsor: Tinh-Hai Collet, MD
Enrollment: 72
Locations: 1
Primary Endpoint: Difference in glucose excursion
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In an exploratory observational pilot study, the investigators will focus on the effects of short-term circadian misalignment induced by shift work on multidimensional measurements including glucose excursion, metabolic health, circadian rhythms (measured in vitro and in vivo), sleep/wake cycles and ambient light, eating and activity patterns, well-being and attention.

Registry

clinicaltrials.gov

Start Date

February 1, 2022

End Date

August 30, 2024

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Tinh-Hai Collet, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Tinh-Hai Collet, MD

Principal Investigator

University Hospital, Geneva

Eligibility Criteria

Inclusion Criteria

•Men and women
•Age 20-50 years
•Working ≥ 80% full-time equivalent over the previous month and during the study
•Working night shifts (i.e. shifts that comprise working hours between 23h and 06h) in rotation with day shifts (i.e. shifts that comprise working hours between 06h and 20h)
•Planned to work at least 3 consecutive night shifts during the study preceded by at least a day off or day shift
•Planned to work at least 3 consecutive day shifts during the study
•Confident use of a smartphone compatible with the study application (iOS, Android) and able to regularly take pictures of consumed food/drinks
•Able to give a fully informed consent and follow the study procedures

Exclusion Criteria

•Planned or current pregnancy during the study
•Menopausal women
•Major illness or hospitalization over the previous month
•Carries a pacemaker, pump or other medical device that can be disabled by a magnet
•Major mental illness
•Trip to a different time zone (≥ 2-hour time difference) over the previous month or planned during the study
•Enrolled in an interventional clinical trial (potentially interfering with the main outcomes) over the previous month or planned during the study

Outcomes

Primary Outcomes

Difference in glucose excursion

Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months

As measured by Continuous Glucose Monitoring

Secondary Outcomes

Difference in systolic and diastolic blood pressure(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in sleep quality(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in fasting glucose(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in lipid profile(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in blood hormonal profile(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in waist circumference(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in nutrient intake(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in sleep/wake cycles(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in weight(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in eating duration(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in heart rate variability(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in physical activity(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in well-being(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in attention and sleepiness(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
Difference in mental health outcomes(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)